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Neuro-Music Therapy for Recent Onset Tinnitus: Evaluation of a Therapy Concept

G

German Center for Music Therapy Research

Status

Unknown

Conditions

Tinnitus

Treatments

Behavioral: Music-therapeutical stress management coaching
Behavioral: Neuro-Music Therapy after waiting time
Behavioral: Neuro-Music Therapy immediately

Study type

Interventional

Funder types

Other

Identifiers

NCT01566708
00.181.2011 (Other Grant/Funding Number)
CMTR-TA-01

Details and patient eligibility

About

To date, the pharmacological treatment options for tinnitus are unsatisfactory. For acute tinnitus drug treatments are only rated as being successful in approximately half of all cases. Therefore, the purpose of this study is to evaluate a neuro-music therapeutic approach (the "Heidelberg Model of Music Therapy") as a new treatment option for patients with recent onset tinnitus after initial medical treatment has failed.

Full description

Acute tinnitus is the phenomenon of ringing or buzzing in the ears without an external sound source that is persisting for a maximum of three month. Several pharmacological treatment options for acute tinnitus have been established. Nonetheless, after initial medical intervention, tinnitus symptoms are often persisting and leading to substantial distress.

The objective of the present study is to examine the efficacy of the "Heidelberg Model of Music Therapy" for patients with recent onset tinnitus whose tinnitus symptoms are enduring after pharmacological treatment. The "Heidelberg Model of Music Therapy" is a manualized short term music therapeutic intervention lasting for 9 consecutive 50-minutes sessions of individualized therapy. It strives for an integration of strategies to manage the psychological state and possibly restore the underlying neurophysiological reorganisation. At the basis of this music therapy concept is the notion that tinnitus is experienced as an auditory percept - just as musical stimuli are experienced as auditory percepts. An outstanding feature of this treatment approach is the way in which patients actively influence their symptoms. This leads to an improved self-efficacy and a more differentiated picture of their symptomatology.

For patients with chronic subjective tinnitus the "Heidelberg Model of Music Therapy" has proven to be an efficient means to reduce tinnitus distress and loudness. Prior studies indicate that these positive results are due to the beneficial influence of the music therapy on the neuronal structures underlying tinnitus pathology.

In the present study the effects of the music therapeutic intervention on tinnitus severity and tinnitus distress for patients with acute tinnitus are evaluated on the basis of a battery of psychological tests as well as psycho-physiological measurements. A task-based functional magnetic resonance imaging (fMRI) paradigm is used to investigate alterations in neuronal networks supposed to be involved in tinnitus perception and chronification.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of acute tinnitus persisting for a maximum of 3 month
  • Adults, aged 18 or over
  • No contraindication for MRI scan
  • Initial medical intervention is accomplished
  • Patients are able to understand, read and speak German fluently
  • Patients are able to give written informed consent

Exclusion criteria

  • Clinical diagnosis of chronic tinnitus persisting for longer than 3 month
  • Tinnitus related to anatomic lesions of the ear, to retrocochlear lesions or to cochlear implantation
  • Clinical diagnosis of severe mental disorder
  • Clinical diagnosis of Menière's Disease
  • Severe hyperacusis
  • Severe hearing impairment
  • Any contraindication for MRI scan
  • Initial medical intervention is not accomplished
  • Patients are not able to understand, read and speak German fluently
  • Patients are not able to give written informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 3 patient groups

treatment group
Experimental group
Treatment:
Behavioral: Neuro-Music Therapy immediately
waiting list group
Active Comparator group
Treatment:
Behavioral: Neuro-Music Therapy after waiting time
control group
Active Comparator group
Treatment:
Behavioral: Music-therapeutical stress management coaching

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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